Imuflex WB-SP Blood Bag System

Generic name: dextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid and sodium phosphate, monobasic

NDC 53877-010-01

CPD SOLUTION
For the collection of 500 mL of Whole Blood

FULL PRESCRIBING INFORMATION
*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].

1. INDICATIONS AND USAGE

1.1. Read these instructions carefully before use.

1.2. Rx ONLY.

1.3. Intended for the collection, processing and preservation of Whole Blood. Not intended for direct intravenous infusion.

1.4. For the collection of 500 mL ±10% Whole Blood.

1.5. Integral Diversion Blood Sampling Arm is intended to divert and obtain donor samples for laboratory testing prior to collection of the Whole Blood unit.

1.6. Integral filter unit intended for leukocyte reduction of Whole Blood up to 8 hours after blood collection when Whole Blood is stored at ambient temperature.

2. DOSAGE AND ADMINISTRATION

2.1. Prepare the blood bag following your institution's standard operating procedures.

2.2.1. Materials Needed : Evacuated blood collection tubes (glass or plastic)

2.2. Make a loose knot in the donor tubing below the "Y" and CLIKTIP® (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.

2.3. Temporarily clamp donor tubing between the phlebotomy needle and the "Y".

2.4. Suspend the collection bag as far as possible below the donor's arm.

2.5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.

2.6. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.

2.6.1. CAUTION: Do not touch the needle after removing the needle cover.

2.7. Secure the needle safety device in place following the device instructions provided on the reverse side.

2.8. Secure donor tubing to donor's arm.

2.9. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. When the level of blood in the pouch is approximately in line with the notches, the diversion pouch is full. (Fig. 2a)

2.9.1. NOTE: The approximate fill volume of the pouch at the notches is 35 mL.

2.10. Permanently seal the tubing between the "Y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor (Fig. 2b).

2.10.1. CAUTION: Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.

2.11. To initiate blood flow into the collection bag, break the CLIKTIP between the "Y" and the collection bag.

2.12. To avoid cl.